Lymphoma (Adult)
Pilot Trial of Alemtuzumab and Dose-Adjusted EPOCH in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas
NCI-03-C-0304
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Investigator(s): |
Wyndham H. Wilson, M.D., Ph.D. Principal Investigator Phone: 301-435-2415 wilsonw@mail.nih.gov
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Peggy Shovlin, R.N., B.S.N. Research Nurse Phone: 301-594-6597 mshovlin@mail.nih.gov
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Primary Eligibility:
- Diagnosis of aggressive T- or NK-cell lymphoma including, but not limited to, any of the following:
- Peripheral T-cell lymphoma not otherwise specified
- Gamma-delta hepatosplenic T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
- CD52-positive disease by pathology or flow cytometry
- T- and NK-cell malignancy without accessible tissue for flow cytometry analysis allowed
- No prior chemotherapy
- No prior or concurrent radiotherapy
- No anaplastic large cell lymphoma (ALCL) except alk-negative ALCL
- No T-cell precursor disease
- No active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year
Treatment Plan:
This is a pilot, dose-escalation study of alemtuzumab.
- Patients receive alemtuzumab IV over 12 hours on day 1 and EPOCH chemotherapy comprising etoposide IV, doxorubicin IV, and vincristine IV continuously over 96 hours on days 1–4; cyclophosphamide IV over 15 minutes on day 5; and oral prednisone twice daily on days 0-5
- Patients also receive filgrastim subcutaneously starting on day 6
- Treatment repeats every 21 days for 6–8 courses in the absence of disease progression or unacceptable toxicity
- Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 6/18/08
Updated: 10/14/08